Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT06798818
Eligibility Criteria:
Inclusion Criteria:
* Patient resuscitated after extra- or intra-hospital cardiac arrest, from presumed cardiac or asphyxial origin, regardless of the heart rate initially recorded.
* Age between 18 and 84 years old
* Time between collapse and return of spontaneous circulation (ROSC) \< 60 min
* Presumption, at the time of inclusion, of a possibility of starting Vent2Cool within a period of less than 120 min after ROSC.
* Unconscious (GCS \<8, not able to obey verbal commands after sustained ROSC)
* Patient affiliated with a social security system (If applicable)
* Consent of the member of patients' family or that of the trusted person if present and able to understand; otherwise certificate of emergency inclusion in compliance with applicable regulations.
* Vent2Cool must be connected to a standard cuffed ETT of 7.0 mm to 9.0 mm internal diameter for the procedure.
Exclusion Criteria:
* Conscious patient
* Patient Ideal Body Weight less than 40 kgs or more than 93 kgs
* Traumatic cardiac arrest, drowning, exsanguination, or sepsis
* Temperature at admission \< 34.0°C
* Need for veno-arterial extracorporeal circulation (Extracorporeal membrane of oxygenation, ECMO) before return of spontaneous circulation (refractory cardiac arrest)
* One of the following signs at echocardiography at hospital admission:
* Acute cor pulmonale, defined by right ventricular enlargement with interventricular septal deviation, associated with a Tricuspid Annular Plane Systolic Excursion (TAPSE) \< 12 mm and need for vasopressor agents
* Time-velocity integral of subaortic flow \< 10 m/s
* Wrong positioning or damage of the endotracheal tube.
* Women under 50 years old (childbearing age) or for women of \>50 years old, a positive pregnancy test (urinary) in case of pregnancy suspicion by the investigator. Possible breastfeeding during the study.
* Suspicion of intracranial bleeding
* History of severe Chronic Obstructive Pulmonary Disease (COPD) with long-term home oxygen therapy
* Acute respiratory pathology (pneumothorax, pleurisy, pneumonia, suspicion of contusion or intra-pulmonary hemorrhage following resuscitation)
* COVID-19 positive test in case of clinical suspicion and/or epidemic context
* Excessive mucus in the upper airways
* Patient presenting at least one of the following criteria in the mechanical ventilation parameters at inclusion:
* PEEP \> 8 cm H2O
* Plateau pressure\> 25 cmH2O
* Driving pressure\> 15cmH2O
* Patient with at least one of the following criteria at inclusion:
* PaO2\< 80 mmHg
* PaO2 / FiO2\< 150 mmHg
* PaCO2\> 48 mmHg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT06798818
Study Brief:
Protocol Section:
NCT06798818